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Employer: ZIOPHARM Oncology, Inc.
Location: Boston, MA
Job Type: Regular, Full Time
Salary: Dependent Upon Experience
Job Title: Associate Director/ Director, Quality Assurance
ZIOPHARM Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of small molecule cancer drugs. The Company is currently focused on three clinical programs. Further information about ZIOPHARM may be found at www.ziopharm.com.
ZIOPHARM’s operations are located in Boston, MA with an executive office in New York. We are seeking talented, enthusiastic individuals to join our growing team. For employment inquiries, please contact us at email@example.com.
The Associate Director, Quality Assurance will asist in leading the GXP quality program by providing support for assuring current Good Manufacturing Practice (CGMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance with all regulatory statutes including state, federal, and international regulations, and company policies that govern the development of drugs, biologicals and other company products by managing, scheduling and conducting clinical investigator, vendor, contract laboratory and internal audits. In addition, the incumbent will be responsible for assisting in the development and maintenance of the company’s Quality Systems, including the document management system, preparation and maintenece of Standard Operating Procedures (SOPs), the internal training program, review and approval of batch-related documentation, CAPA and deviation review and disposition, process validation and establishment and maintenance of the QA files. The Associate Director will also participate in the development and generation of regulatory submissions to governmental agencies worldwide, as required.
Responsibilities will include, but are not limited to, the following:
• Verify that studies (clinical and non-clinical) are conducted in compliance with federal regulations and protocol requirements
• Verify that data submitted to Regulatory Agencies in support of Investigational New Drug (IND), Clinical Trials Application (CTA) or Marketing Applications are supported by adequate and relevant source documentation
• Verify that drug substance and drug product are manufactured according to CGMPs
• Assure that activities conducted on behalf of the company are in complaince with applicable laws, regulations and company policies by conducting audits of vendors, including manufacturers, contract labs and nonclinical and clinical research sites.
• Audit databases and study reports prepared by various groups within the compamy
• Audit regulatory submissions to assure accuracy
• Report findings and risk assessment of deficiencies and deviations from company standards to the head of Quality.
• BA/BS in a scientific discipline, advanced degree preferred.
• Minimum of 7 to 10 years experience in a combination of quality assurance, biomedical science, regulatory compliance, or clinical study monitoring/auditing, or the equivalent.
• Candidate will ideally have existing quality assurance experience.
• A broad understanding of the drug development process is required.
Knowledge, Skills, and Abilities:
• Thorough knowledge of U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH Good Clinical Practice Guidelines, and an understanding of GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211).
• The ability to analyze data, determine root cause of deficiencies, and provide recommendations for resolution.
• Demonstrated ability to independently review clinical protocols, informed consents, and monitoring and data management plans.
• Ability to manage the document management system, including preparation and maintenance of SOPs, implementation of the internal training program, review and approval of batch-related documentation, CAPA and deviation investigations, and maintenance of quality-related files
• Demonstrated ability to manage the quality aspects of process validation
• Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology
• Excellent interpersonal skills.
• The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Understand the drug and biologic development process, clinical research process including medical & clinical terminology, non-clinical research process including terminology, manufacturing processes including terminology
To apply, please send your resumes via email by clicking APPLY NOW below. Indicate the job title in the subject line of the email. The Human Resources department will review your resume and will contact you if your credentials appear to meet the position requirements. No agencies, please.